Replacing
confusing language and icons on standard warnings labels for
prescription medicine and listing only the most important warnings
could make a big difference in how well patients understand the
instructions that are critical to their health, according to a new
study from Northwestern University Feinberg School of Medicine.

Simple,
concise language on warning labels of prescription medicine bottles is
easier for patients to understand than the standard wording commonly
used, according to the study. And the fewer warnings on a label, the
more likely a patient will actually pay attention to them.

For
the study, Northwestern researchers and colleagues worked with patients
and nationally renowned graphic designers to simplify and redesign the
confusing language and icons of standard warning labels. Many of them
have been used for decades without any evidence to show patients
comprehend them, or even if they are true.

"The
study shows the value of a clear message," said Michael Wolf, associate
professor of medicine and of learning sciences at Feinberg and lead
author of the study. "A lot of the current warnings were phrased very
abstractly and were confusing. For example, we changed 'For external
use only' to 'Use only on your skin.' We moved from the intangible to
the concise."

Many
of these label warnings are critical for patients to take their
medications safely. But previous research by Wolf and colleagues found
more than half of adults misunderstand common standard drug warnings,
putting them at risk for using the medicine incorrectly or even having
a life-threatening event.

As
a result of the new findings, Wolf and colleagues from Emory, Harvard
and Louisiana State universities are working with the U.S. Pharmacopeia
on a drug labeling task force to help overhaul the content and use of
these labels.

The
study also found that newly designed icons improved understanding for
patients with low health literacy, a group at greatest risk for
misinterpreting instructions and misusing medications. The paper was
published in a recent issue of Archives of Internal Medicine.

The
graphic designers worked with the researchers and patients to capture
their mental images of what each message means. "A current and widely
used icon of a pregnant woman resembles an olive," Wolf said. "For most
people that probably doesn't convey pregnancy. The new design of a
silhouette of a pregnant woman with a bump on her stomach was more
easily recognizable to patients."

The
design team included Deborah Adler, the co-creator of Target Corp.'s
highly innovative and successful prescription bottle and labeling
system called the ClearRx system, and Milton Glaser, a co-founder of
New York Magazine who is known for creating the "I love NY" logo and a
concert poster for Bob Dylan.

Because
the study found that patients ignore too many warnings on the bottle,
Wolf recommends a limit of two. Those should include the most important
few, and these should have evidence confirming their necessity.

Several
warning labels found on pill bottles today were created years ago
without a scientific base, Wolf said. "There may not be a reason to use
many of these," he noted. "And with such limited real estate on a pill
bottle, the fewer the better. Our study supports that."

"We
need to out which are the most important warnings and only put those on
the label. Otherwise you risk the message never reaching the patient,"
Wolf said. "The more warnings you put on a label, the more you distract
them from essential instructions and precautions that ensurethey safely
use the medicine."

The
study included 500 adult patients from two academic and two community
health clinics in Chicago and Shreveport, La. The patients were tested
on their interpretation of nine drug warning labels that were:

1)
current standard drug warning labels on prescription
containers;

2)
drug warnings with text rewritten in simplified language or

3) labels with simplified language and icons developed with patient
feedback.

The
patients reading standard labels had an 80 percent rate of correct
interpretations, simplified text was 91 percent and simplified text
with new icons was 92 percent.

"Our
findings underscore the importance of including patients in the process
and using meaningful, plain language to support their understanding and
proper use of their medicine," Wolf said.

The
study was funded by Target Corp. and the Agency for Healthcare Research
and Quality.